Full text

Turn on search term navigation

© 2022 Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

Sepsis is not only the leading cause of death in the intensive care unit (ICU) but also a major risk factor for physical and cognitive impairment and mental disorders, known as postintensive care syndrome (PICS), reduced health-related quality of life (HRQoL) and even mental health disorders in patient families (PICS-family; PICS-F). The ABCDEF bundle is strongly recommended to overcome them, while the association between implementing the bundle and the long-term outcomes is also unknown.

Methods and analysis

This is a multicentre prospective observational study at 26 ICUs. All consecutive patients between 1 November 2020 and 30 April 2022, who are 18 years old or older and expected to stay in an ICU for more than 48 hours due to sepsis or septic shock, are enrolled. Follow-up to evaluate survival and PICS/ PICS-F will be performed at 3, 6 and 12 months and additionally every 6 months up to 5 years after hospital discharge. Primary outcomes include survival at 12 months, which is the primary outcome, and the incidence of PICS defined as the presence of any physical impairment, cognitive impairment or mental disorders. PICS assessment scores, HRQoL and employment status are evaluated. The association between the implementation rate for the ABCDEF bundle and for each of the individual elements and long-term outcomes will be evaluated. The PICS-F, defined as the presence of mental disorders, and HRQoL of the family is also assessed. Additional analyses with data up to 5 years follow-up are planned.

Ethics and dissemination

This study received ethics approvals from Saiseikai Utsunomiya Hospital (2020-42) and all other participating institutions and was registered in the University Hospital Medical Information Network Clinical Trials Registry. Informed consent will be obtained from all patients. The findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

UMIN000041433.

Details

Title
Effects of evidence-based ICU care on long-term outcomes of patients with sepsis or septic shock (ILOSS): protocol for a multicentre prospective observational cohort study in Japan
Author
Liu, Keibun 1   VIAFID ORCID Logo  ; Kotani, Toru 2 ; Nakamura, Kensuke 3 ; Takai Chihiro 4 ; Morita, Yasunari 5 ; Ishii, Kenzo 6 ; Fujizuka, Kenji 7 ; Yasumura, Daisetsu 8 ; Taniguchi, Daisuke 9 ; Hamagami, Tomohiro 9 ; Shimojo, Nobutake 10 ; Nitta, Masakazu 11 ; Hongo, Takashi 12 ; Akieda, Kazuki 13 ; Maeda Atsuo 14 ; Kaneko, Tadashi 15 ; Sakuda, Yutaka 16 ; Andoh, Kohkichi 17 ; Nagatomi, Akiyoshi 18 ; Tanaka, Yukiko 19 ; Irie, Yuhei 20 ; Kamijo, Hiroshi 21 ; Hanazawa, Manabu 22 ; Kasugai, Daisuke 23 ; Matsuoka Ayaka 24 ; Oike, Kenji 25 ; Lefor, Alan Kawarai 26 ; Takahashi, Kunihiko 27 ; Katsukawa, Hajime 28 ; Ogura, Takayuki 4 

 Critical Care Research Group, The Prince Charles Hospital, Brisbane, Queensland, Australia 
 Department of Intensive Care Medicine, Showa University School of Medicine, Tokyo, Japan 
 Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan 
 Department of Emergency Medicine and Critical Care Medicine, Tochigi prefectural emergency and critical care center, Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan 
 Department of Emergency and Intensive Care Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan 
 Department of Anesthesiology, Intensive Care Unit, Fukuyama City Hospital, Fukuyama, Hiroshima, Japan 
 Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital, Maebashi, Maebashi, Japan 
 Department of Rehabilitation, Naha City Hospital, Naha, Okinawa, Japan 
 Tajima Emergency & Critical Care Medical Center, Toyooka Public Hospital, Toyooka, Japan 
10  Emergency and Critical Care Medicine, University of Tsukuba Faculty of Medicine, Tsukuba, Ibaraki, Japan 
11  Department of Intensive Care Unit, Niigata University Medical and Dental Hospital, Niigata, Niigata, Japan 
12  Emergency Department, Okayama Saiseikai General Hospital, Okayama, Japan 
13  Department of Emergency Medicine, SUBARU Health Insurance Society Ota Memorial Hospital, Ota, Japan 
14  Department of Emergency and Disaster Medicine, Showa University Fujigaoka Hospital, Yokohama, Kanagawa, Japan 
15  Emergency and Critical Care Center, Mie University Hospital, Tsu, Mie, Japan 
16  Department of Intensive Care Medicine, Okinawa Kyodo Hospital, Naha, Okinawa, Japan 
17  Division of Anesthesiology, Sendai City Hospital, Sendai, Miyagi, Japan 
18  Department of Emergency medicine and Critical Care, St. Marianna University School of Medicine, Yokohama-City Seibu Hospital, Yokohama, Japan 
19  Department of emergency, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan 
20  Department of Emergency and Critical care medicine, Fukuoka University Hospital, Fukuoka, Japan 
21  Intensive Care Unit, Shinshu University Hospital, Matsumoto, Nagano, Japan 
22  Department of Rehabilitation, Japan Red Cross Narita Hospital, Narita, Japan 
23  Department of Emergency and Critical Care Medicine, Nagoya University Graduate School of Medicine Faculty of Medicine, Nagoya, Aichi, Japan 
24  Department of Emergency and Critical Care Medicine Faculty, Saga University Hospital, Saga, Saga, Japan 
25  Department of Rehabilitation, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan 
26  Department of Surgery, Jichi Medical University, Shimotsuke, Japan 
27  M & D Data Science Center, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan 
28  Japanese Society for Early Mobilization, Tokyo, Japan 
First page
e054478
Section
Intensive care
Publication year
2022
Publication date
2022
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3117719437
Copyright
© 2022 Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.